CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Non-formulary drug / autoimmune therapy prior authorization and continuation criteria

Defines authorization criteria for non-formulary drug requests (particularly autoimmune therapies), continuation of therapy criteria, and coverage duration for commercial and Medicaid populations; references formulary compendia and internal formulary management policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNon-formulary drug / autoimmune therapy prior authorization and continuation criteria

Policy CodePolicy N/A

Change TypeClarified (no material change)

Effective DateApr 1, 2019

Next Review Date

Key ActionSubmit prior authorization only when dosing aligns with FDA or compendia guidelines and required trials of formulary alternatives are documented or a rationale is provided if alternatives are unavailable.

POLICY UPDATE CHANGES

Policy references formulary management policy and multiple review dates through 08/2025.

12 monthsMaximum Coverage Duration

2Required prior formulary alternatives (typical)

4Reference compendia listed

Coverage Summary

This policy defines the scope for non-formulary exception requests for autoimmune therapies. Authorization may be granted when the prescribed dose and quantity are within FDA-approved labeling or compendia-supported dosing guidelines, and the requested product is used for an FDA-approved indication or a medically accepted indication supported by listed compendia or peer-reviewed literature. Prior trials of formulary alternatives are required (typically two comparable formulary alternatives) with allowance for alternative logic if fewer exist; when no comparable formulary alternatives exist, a documented rationale for medical necessity is required. Coverage duration is up to 12 months. The scope also references the internal formulary management policy for applicable commercial and Medicaid populations.

Initial Therapy Criteria

Initial Approval Criteria

An authorization may be granted when all the following criteria are met:

ALL of the following

The prescribed dose and quantity fall within the FDA-approved labeling or within compendia-supported dosing guidelines.
The requested drug/product is used for an FDA-approved indication or a medically accepted indication as defined in one of the standard reference compendia (AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs) or peer-reviewed published medical literature supporting use.
One of the following
- When comparable formulary alternatives exist
  - Patient has experienced an inadequate treatment response or intolerance to two comparable formulary alternatives for the same indication, including generic and biosimilar alternatives if available.
  - If there are less than two comparable formulary alternatives available for the same indication, the patient has experienced an inadequate treatment response or intolerance to all of the available formulary alternatives, including generic and biosimilar alternatives if available.
- When no comparable formulary alternatives exist
  - Rationale is provided for why the requested drug/product is medically necessary.
  - Patient has tried, failed, or has a contraindication to all products available on the formulary indicated to treat the patient's autoimmune condition (at least one product available on the formulary).
For commercial autoimmune non-formulary exception requests (examples listed: Taltz, Tremfya, Otezla, Skyrizi for Psoriasis or Psoriatic Arthritis), additional commercial-specific criteria may apply.
Policy references but text incomplete in source; implies special handling for certain agents.

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Continuation Therapy Criteria

Continuation of Therapy

Authorization continued when ALL of the following are met:

ALL of the following

Patient meets all initial criteria in section I.
Patient has disease stabilization or improvement in disease as defined by established clinical practice guidelines.
Patient is tolerating treatment and is not experiencing any unacceptable toxicity from the drug.

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Billing Rule

Coverage duration limit

Note: Coverage duration is up to 12 months as determined by FDA guidance and internal policies and procedures.

Maximum: 12 months

Provider Actions & Requirements

Prior Authorization

Prior authorization required for non-formulary exception

An authorization (prior authorization) may be granted only when the documented criteria are met, including dosing within FDA or compendia guidelines and prior trials of formulary alternatives or documented rationale if none exist.

Documentation Required

Documentation of trials or rationale

Provider must document inadequate response or intolerance to required numbers of formulary alternatives or provide rationale for medical necessity when no comparable formulary alternatives exist.

Typical required prior formulary alternatives: 2

Billing Rule

Coverage duration

Coverage duration is up to 12 months as determined by FDA guidance and internal policies and procedures.

Background

Background: This is a non-formulary exception policy for autoimmune therapies that requires prescribing within FDA labeling or compendia-supported dosing guidelines. Use must be for an FDA-approved indication or a compendia-supported/medically accepted indication. Prior trials of formulary alternatives are required—typically failure or intolerance to two comparable formulary alternatives (including generics and biosimilars when available); if fewer than two alternatives exist, the patient must have tried and had inadequate response or intolerance to all available formulary alternatives, or provide rationale when no comparable alternatives exist. Continuation of therapy requires meeting initial criteria, evidence of disease stabilization or improvement per clinical practice guidelines, and tolerability without unacceptable toxicity. The policy references the NHPRI Formulary Management Policy and Procedure for additional formulary management guidance.